FDA Adverse Event
Malfunction
Summary report: N
ALUMINA CERAMIC INSERT
MDR report key: 1791210
·
Received August 2, 2010
Report
- Report Number
- 9616680-2010-00491
- Event Type
- Malfunction
- Date Received
- August 2, 2010
- Date of Event
- July 13, 2010
- Report Date
- July 15, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS CORK
- Product Code
- MEH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION PERTAINING TO THE DEVICE(S) REFERENCED IN THIS REPORT WAS REQUESTED. IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT, "SURGEON PLACED A TRIDENT PSL SHELL IN THE ACETABULUM IN 45 DEGREES OF INCLINATION AND THEN INSERTED THE ALUMINA CERAMIC INSERT AND UPON POST OP X-RAY, HE REALIZED THAT THE CERAMIC INSERT WAS SEATED 53 DEGREES OF INCLINATION. THEREFORE, THE SURGEON FELT THAT THE INSERT DID NOT SEAL CORRECTLY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ALUMINA CERAMIC INSERT | IMPLANT | MEH | STRYKER ORTHOPAEDICS CORK | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |